About this trial
Traumatic rib fractures (i.e., broken ribs caused by a physical injury) are common and very painful. They also often lead to serious complications, more time spent in hospital, and can even lead to death. Even after rib fractures have healed, they can lead to long-term pain and a lower quality of life.
A technology called cryoneurolysis, which acts to freeze nerves causing pain using a small tool which can turn very cold, is a promising new way to manage rib fracture pain. This study is a test with a small number of people to see if it is feasible to use this technology for patients with rib fractures. If this is successful, we will recruit more people for a larger study to see if cryoneurolysis, along with standard pain control techniques, is better at stopping pain, compared to just the normal techniques alone. Participants in our study will be asked to rate their pain, and record pain medications that they take for 3 months after their pain procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18
Unilateral traumatic rib fractures (3 to 8)
Candidate for ESP block catheter
Within 48hrs of admission to hospital
Disqualifiers
Lack of patient consent; unlikely to comply with follow up
Unable to use Patient Controlled Regional Analgesia (Ventilated/sedated patients or Moderate to severe traumatic brain injury)
Chronic pain (opioid use > 30mg oral morphine equivalent per day)
Substance use disorder
Trial design
Parallel
Treatments tested in this trial
Cryoneurolysis
Procedure/SurgeryCryoneurolysis will be performed on the intercostal nerve associated with each fractured rib using a handheld cryoneurolysis machine (Iovera). Cryoneurolysis will consist of two 103 second cycles (includes cooling, ice ball formation and warming time) per rib fracture level. Ultrasound guidance will be used to identify appropriate rib fracture levels and to target the device tip in real time. All participants will also receive standard multimodal analgesia and ESP catheter infusion.
Sham Cryoneurolysis
Procedure/SurgeryParticipants in the control group will receive sham CN (i.e., application of device without skin puncture or activation of unit) to maintain participant blinding. All participants will also receive standard multimodal analgesia and ESP catheter infusion.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants randomized over an 8 month period
Goal of 3 participants per month for 8 months
Number of participants able to adhere to the protocol
Goal of \> 90%
Number of participants able to adhere to the follow-up
Goal of \> 90%
Rate of Adverse events
Ensure no adverse events (short or long term) associated with CN
Secondary outcomes
Pain Severity during deep inspiration 24 hours post ESP catheter placement
Pain measured using Numeric Pain Rating Scale
Time to discontinuation of ESP catheter
Based on when patient has met criteria for APS discharge or pain is controlled such that PCRA use is \< 2 boluses over 12 hrs and NRS \< 3 with deep breathing and coughing
ESP catheter use
Cumulative volume of local anesthetic solution used via ESP catheter patient controlled reginal analgesia
Opioid consumption in hospital and after discharge
Determined from medical records (in-hospital) and via a daily pain diary (post-discharge). Calculated in Oral Morphine Equivalents.
Other outcomes
Pain Intensity
As measured using NRS-11, at rest and during deep inspiration
Sponsors and contacts
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